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DESCRIPTIONInterferon gamma-1b (Actimmune®) is a recombinant form of gamma interferon and is derived from genetically engineered Escherichia coli. Interferons, in general, are species-specific proteins produced in response to viruses as well as a variety of other stimuli. Interferon gamma is a Type II interferon or immune interferon, which is produced by T-cells and natural killer (NK) cells after activation with immune or inflammatory stimuli. Interferon gamma may be better described as an interleukin since it is: 1) produced by activated T lymphocytes, 2) regulates the activity of immune cells, and 3) interacts with other interleukins as part of the lymphokine regulatory network.
Interferon gamma enhances production of superoxides which allows more efficient killing of certain fungi, bacteria, and protozoal microbes, including Staphylococcus aureus, Aspergillus fumigatus, Chlamydia psittaci, Plasmodium falciparum, Leishmania donovani, Toxoplasma gondii, and Listeria monocytogenes. Interferon gamma also increases recruitment of leukocytes to sites of infection or inflammation and increases intracellular concentrations of certain antimicrobials, including macrolides and quinolones. This activity is important in the ability of interferon gamma to clear infections.
Interferon gamma has direct and indirect antiviral activities. Indirect actions are due to its effect on immune responses including antigen processing and presentation and induction of antiviral, cellular, and humoral immune responses. Interferon gamma has direct antiviral activity in host cells by affecting attachment, penetration, uncoating, transcription, assembly, and maturation of viruses. It also inhibits viral translation. Interferon gamma induces cellular resistance to cytomegalovirus, herpes simplex virus, and adenovirus in vitro.
FDA APPROVED INDICATIONS
Interferon gamma-1b (Actimmune®) is indicated for reducing the frequency and severity of serious infections associated with Chronic Granulomatous Disease (CGD). It is also indicated for delaying time to disease progression in patients with severe, malignant osteopetrosis (added 09-06-2006).
POLICYPrior authorization is required.
Interferon gamma-1b (Actimmune®) is considered medically necessary for the treatment of Chronic Granulomatous Disease and for delaying of time to disease progression of severe, malignant osteopetrosis.
The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.
POLICY HISTORY10/21/2003: Approved by Pharmacy & Therapeutics Committee (P & T)
8/15/2005: Code Reference section reviewed, no changes
09/06/2006: FDA approved section added. Accredo information updated.
12/31/2008: Code Reference section updated per the 2009 CPT/HCPCS revisions
01/01/2009: Accredo preferred provider information removed. BCBSMS information added.
SOURCE(S)Clinical Pharmacology Online
Bolinger AM, Taeubel MA. Recombinant gamma interferon for the treatment of chronic granulomatous disease and other disorders. Clin Pharm 1992;11:834-50.
Lexi-Comp Online (added 09-06-2006)
Actimmune® Prescribing Information (added 09-06-2006)
CODE REFERENCEThis may not be a comprehensive list of procedure codes applicable to this policy.
The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.